The Effectiveness of a Mechanical Debridement Instrument in Reducing Bioburden in Chronic Wounds

This prospective clinical trial will compare the bacterial burden in the wound bed and on the periwound skin before and after mechanical debridement with EZ Debride using fluorescence imaging.

After consenting, the ulcers of eligible subjects are measured, photographed and undergo the MolecuLight imaging procedure (MLiX). The ulcer is mechanically debridement with the EZ Debride device after which a second MLiX procedure is performed. The investigator will then compare the two images.

Study Overview

• Status: Completed
• Conditions: Chronic Wounds; Acute Wounds
• Intervention / Treatment: Device: EZ Debride®

Detailed Description

Acute and chronic wounds burden healthcare systems across the globe. In the United States the cost of nonhealing wounds approximates 100 billion dollars.1-3 The presence of bacteria in and around the wound impedes wound healing. Clinicians treat elevated wound bacterial levels with mechanical and sharp debridement, topical antiseptics and systemic antibiotics. However, evidence on the best methods to reduce bacterial load is lacking. The EZ-1 clinical trial will utilize the latest fluorescence imaging technology to investigate whether mechanical debridement using the EZ Debride® tool reduces bacterial burden.

• Study Type: Observational
• Enrollment (Actual): 28

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15222
      • Serena Group Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with acute or chronic wounds

Description

Inclusion Criteria:

1. Adult patients with acute or chronic wounds that have been present for a minimum of 4 weeks.
2. A signed and dated informed consent form.
3. Subject is willing and able to comply with instructions and scheduled visits.

Exclusion Criteria:

1. The Subject has other concurrent conditions that in the opinion of the Investigator may compromise subject safety.
2. The subject's wound has not been present for at least 4 weeks.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Bacterial Bioburden	The reduction in bacterial bioburden following mechanical wound debridement as determined by the MolecuLight Procedure (MLiX).	Before and After Mechanical debridement within 1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Score	Pain scores (PEG) before, during and after mechanical debridement. Pain intensity of the reference ulcer is assessed before and after any wound cleansing using the PEG score PEG Scale Assessing Pain Intensity and Interference (Pain, Enjoyment, General Activity). The PEG scale is a validated pain scoring system. It consists of three 1-10 rating scales: numerical, enjoyment of life and general activity. The subject indicates a numerical value that best represents the pain intensity at ulcer site on a scale of 0 to 10 anchored by word descriptors at each end, as "no pain" on the left side and "Pain as bad as you can imagine" on the right side of the number line. The number 0 represents "no pain", the number 5 represents "moderate pain" and the number 10 represents the "worst possible pain".	Before, during, and after mechanical debridement within 1 hour
Adverse Events	Adverse events associated with mechanical debridement.	During debridement

Collaborators and Investigators

• Sponsor: SerenaGroup, Inc.
• Collaborators: MDM Wound Ventures, LLC

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 19, 2020
• Primary Completion (ACTUAL): June 16, 2020
• Study Completion (ACTUAL): June 16, 2020

Study Registration Dates

• First Submitted: April 7, 2020
• First Submitted That Met QC Criteria: April 9, 2020
• First Posted (ACTUAL): April 13, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 18, 2021
• Last Update Submitted That Met QC Criteria: March 17, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: EZ-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes